Facchin Sonia, Buda Andrea, Cardin Romilda, Agbariah Nada, Zingone Fabiana, De Bona Manuela, Zaetta Debora, Bertani Lorenzo, Ghisa Matteo, Barberio Brigida, Savarino Edoardo Vincenzo
Department of Surgery, Oncology and Gastroenterology (DISCOG), University Hospital of Padua, Padua, Italy.
Department of Oncological Gastrointestinal Surgery, Gastroenterology Unit, S. Maria del Prato Hospital, Feltre, Italy.
Therap Adv Gastroenterol. 2021 Mar 21;14:1756284821999902. doi: 10.1177/1756284821999902. eCollection 2021.
Anti-drug antibodies can interfere with the activity of anti-tumor necrosis factor (TNF) agents by increasing drug clearance direct neutralization. The presence of anti-drug antibodies is clinically relevant when trough drug concentrations are undetectable or sub-therapeutic. However, traditional immunoassay is not easily and rapidly accessible, making the translation of the results into treatment adjustment difficult. The availability of a point-of-care (POC) test for therapeutic drug monitoring (TDM) might represent an important step forward for improving the management of (IBD) patients in clinical practice. In this pilot study, we compared the results obtained with POC tests with those obtained by enzyme-linked immunosorbent assay (ELISA) in a group of IBD patients treated with Infliximab (IFX). We showed that POC test can reliably detect presence of antibody-to-IFX with 100% of specificity and 76% sensitivity, in strong agreement with the ELISA test (-coefficient = 0.84).
抗药抗体可通过增加药物清除率和直接中和作用来干扰抗肿瘤坏死因子（TNF）药物的活性。当药物谷浓度检测不到或低于治疗水平时，抗药抗体的存在具有临床相关性。然而，传统免疫测定法不易快速获得，使得将结果转化为治疗调整存在困难。用于治疗药物监测（TDM）的即时检验（POC）可能是临床实践中改善炎症性肠病（IBD）患者管理的重要进展。在这项初步研究中，我们比较了一组接受英夫利昔单抗（IFX）治疗的IBD患者通过POC检测与酶联免疫吸附测定（ELISA）所获得的结果。我们发现，POC检测能够可靠地检测出抗IFX抗体的存在，特异性为100%，灵敏度为76%，与ELISA检测结果高度一致（相关系数=0.84）。
